Information on the Phase 3 study of the Influenza vaccine.
This study evaluated the safety and immune responsiveness of a seasonal influenza messenger RNA vaccine from Moderna.
Participants were randomly assigned to two groups. One group received a dose of the modified mRNA platform-based influenza vaccine, while the other group received a dose of the previously licensed seasonal influenza vaccine (comparator group). The objective was to compare the efficacy and safety of both formulations.
The modified mRNA platform has shown excellent results in the development of COVID-19 vaccines (both in safety and efficacy) and, more recently, in a new vaccine against respiratory syncytial virus for adults over 60 years of age.
Safety and tolerability: the vaccine has demonstrated an acceptable safety profile. Most adverse reactions were mild, such as pain at the injection site and symptoms such as headache and fatigue.
Efficacy against influenza: the vaccine has been shown to be superior to the comparator in the generation of antibodies against the A/H3N2 and A/H1N1 strains of influenza. Although the superiority in the generation of antibodies against influenza B strains was not demonstrated, Moderna informed that this finding has been of great importance and they are working on new vaccine formulations to improve the results that did not reach the objectives.
This study included more than 6,000 adults from Argentina, Australia, Colombia, Panama and the Philippines.
